Merck & Co., J&J, Lilly, and Pfizer Lead Pipeline News
A roundup of the latest drug pipeline news, including from the pharmaceutical majors, featuring news from Merck & Co., J&J, Lilly, Astellas, and Pfizer.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday October 11, 2017 to Tuesday October 17, 2017.
Merck & Co. Discontinues Development of Cholesterol Drug Anacetrapib
Merck & Co. will not submit applications for regulatory approval for anacetrapib, a cholesteryl ester transfer protein inhibitor, now in Phase III development as an investigational cholesterol drug.
In August 2017, Merck & Co. announced that the safety of anacetrapib was generally consistent with data from earlier trials of the drug, but a sub-study also showed that anacetrapib accumulates in adipose tissue with prolonged dosing.
The decision follows a review of the clinical profile of anacetrapib, including discussions with external experts.
Source: Merck & Co.
J&J’s Janssen Submits NDA to FDA for Prostate Cancer Drug
Janssen Biotech, part of Johnson & Johnson (J&J), has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for apalutamide, an investigational oral androgen receptor inhibitor for treating men with non-metastatic castration-resistant prostate cancer.
Apalutamide is an investigational oral androgen receptor inhibitor that inhibits the action of testosterone in prostate cancer cells and works by preventing androgen from binding to the androgen receptor.
Source: Johnson & Johnson
FDA Grants Priority Review for New Use of Lilly’s Breast Cancer Drug Verzenio
The US Food and Drug Administration (FDA) has granted priority review to Eli Lilly and Company for its new drug application for Verzenio (abemaciclib), a cyclin-dependent kinase 4 and 6 inhibitor, for treating women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
In the third quarter of 2017, Lilly completed regulatory submissions in the European Union and Japan for abemaciclib for treating breast cancer.
Verzenio is indicated: in combination with fulvestrant for treating women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy; and as monotherapy for treating adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Source: Eli Lilly and Company
FDA Grants Fast-Track Designation to Astellas for Leukemia Drug Gilteritinib
The US Food and Drug Administration (FDA) has granted Astellas Pharma fast-track designation for gilteritinib for treating adult patients with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia.
Fast-track designation is designed to facilitate the development, and expedite the FDA review, of drugs to treat serious and life-threatening conditions.
Fast-track designation for gilteritinib may allow for more frequent meetings and correspondence with the FDA, consideration for priority review if supported by clinical data, and rolling review, which means Astellas can submit completed sections of its new drug application (NDA) for review by the FDA rather than waiting until every section of the application is completed before the NDA can be reviewed.
Source: Astellas Pharma